Nitrosamines in Bioanalysis

Nitrosamines are formed by the reactions between nitrates or nitrites and certain amines. With the discovery of carcinogenic nitrosamine impurities in pharmaceuticals in 2018, N-Nitrosamines categorised as ‘Cohort of concern’ in ICH M7 (R1) guidelines due to their potential mutagenic and carcinogenic nature and thus the regulatory agencies i.e. USFDA/EMA imposed several strict regulations to address, monitor and control its trace levels.

Although, the detection and quantification of these trace nitrosamines in APIs and finished products (solid / liquid orals and biologics) can be challenging hence necessitating the use of advanced tools and standardized testing protocols to meet the regulatory requirements. Additionally, we belive that in light of introduction of ICH M10 BMV guidelines and its specific focus on the extended evaluation of method selectivity in presence of drug related impurities directs a bioanalytical scientist to have a serious insight on detailed selectivity and method optimization protocol, ‘A point to ponder’?